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FDA PDUFA IV Financial Plan Summary

The Agency plan for PDUFA IV is a composite of the plans developed by CDER, CBER, ORA, and OC components. Tables 1-6 on pages 32 and 33 summarize the overall FDA plan. The discussion below summarizes information in each of these tables.

Table 1 shows the total that FDA estimates it will spend from PDUFA fees over each of the next five years. The first six lines of the chart show how the PDUFA IV Fee Base will be allocated by major expense category. (The PDUFA IV Fee Base is the amount spent at the end of PDUFA III, plus the adjustments to that amount made by PDUFA IV as necessary to continue to support the goals of PDUFA III through the 5 years of PDUFA IV.) The chart shows on one line the total amount FDA estimates it will spend on PDUFA IV program enhancements each year and charts 2 and 3 each give a more detailed breakout of this line. The final line gives the total PDUFA IV estimated costs each year. (Estimated costs each year equal total anticipated collections each year.)

Table 2 shows estimates of how the funds FDA plans to spend for PDUFA IV enhancements (next-to-last line of table 1) will be allocated in each of the next five years, by component, planned to meet PDUFA IV goals. The yearly amounts and totals for CDER, CBER, ORA, and OC on the first four lines are from their individual plans. The next three lines show the amounts for: (1) information technology, (2) rent and rent related, and (3) central accounts. These are necessary to meet PDUFA IV goals and to accommodate the additional staff hired by the centers. The total line allocates all the PDUFA IV enhancement funds FDA expects to spend through FY 2012.

Table 3 shows estimates of how the funds FDA plans to spend for PDUFA IV enhancements (next-to-last line of table 1) will be allocated in each of the next five years, by PDUFA IV enhancement category. About $26 million (4% of the increase) will be spent for critical path initiatives. About $164 million (25% of the increase) is planned for drug safety/risk management enhancements. About $22 million (3% of the increase) is planned for IT/electronic submission enhancements. About 258 million (39% of the increases) is planned for implementing the additional drug safety enhancements. About $195 million (29% of the increases) is planned for additional staff to keep up with workload increases.

Table 4 and Table 5 summarize the allocation of the total amount available from PDUFA IV fees each year (PDUFA IV Fee Base plus enhancements) will be spent over each of the next 5 years by component (table 4) and by major expense category (table 5). These are similar to table 2 and 3, but include all PDUFA IV fee funds available not just enhancements. In table 4, by component, CDER will be allocated 59 percent, CBER 10 percent, ORA 1 percent, overhead 8 percent, information technology 8 percent, rent and rent related costs 7 percent, and central accounts 7 percent. In table 5, by major expense categories, 60 percent of the total PDUFA IV revenues will be dedicated to pay and benefits for staff, 18 percent for operating costs, 8 percent for IT, 7 percent for rent and rent related costs, and 7 percent for central accounts.

Table 6 summarizes the total staff years planned each year for the process for the review of human drug applications, showing the number of staff years paid from the salary and expense appropriations, the number of staff years paid from fees and considered funded by the PDUFA IV fee base, and the number of staff years added over the course of PDUFA IV under this plan.